Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans

NCT03340350 | Completed Phase 4 Results FDA Drug

• 1 other identifier: RAM-01068
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the safety and efficacy of adjunctive minocycline treatment in veterans with PTSD.

Conditions

PTSD

Keywords

Minocycline; PTSD

Outcome Measures

Primary Outcomes (4)

• PTSD Symptom Severity

  PTSD symptom severity was assessed using total scores on the Past Month version of the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5). Total scores on the CAPS-5 range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

  Baseline and Week 12

• Change in C-reactive Protein (CRP) Level

  Measure of inflammation

  Screening and Week 12

• Change in Interleukin 6 (IL-6) Level

  Measure of inflammation

  Screening and Week 12

• Change in Tumor Necrosis Factor Alpha (TNF-α) Level

  Measure of inflammation

  Screening and Week 12

Secondary Outcomes (5)

• Depression Symptom Severity

  Screening and Week 12

• Clinical Status (Severity)

  Baseline and Week 12

• Clinical Status (Improvement)

  Baseline and Week 12

• Executive Functioning (Set Shifting)

  Baseline and Week 12

• Executive Functioning (Verbal Fluency)

  Baseline and Week 12

Study Arms (1)

Minocycline

EXPERIMENTAL

Minocycline 100 mg/day 1 to 7 and 200 mg/day 8 to end of week 12

Drug: Minocycline

Interventions

Minocycline DRUG

Minocycline capsule

Also known as: Minocycline hydrochloride capsule

Minocycline

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans between the ages of 19 and 65 who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for chronic PTSD.
• Patients who have been taking an adequate dose of selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) medication, bupropion, or mirtazapine for a minimum of 8 weeks at the time of study entry.
• PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score of \> 33 at the Screening Visit. Eligible persons will be allowed to have other symptoms that are commonly comorbid with PTSD (e.g., anxiety, somatic symptoms). This strategy will provide a feasible and generalizable sample of those with chronic PTSD.

You may not qualify if:

• Patients with a concurrent DSM-5 diagnosis in any of the following categories:
• Major Neurocognitive Disorder (NCD) 1.2. Lifetime Schizophrenia and other Psychotic Disorders 1.3. Lifetime Bipolar Disorder 1.4. Alcohol Dependence or Abuse in 3 months prior to the Screening Visit 1.5. Any other Substance Dependence or Abuse (excluding nicotine) in 12 months prior to the Screening Visit 1.6. Any other concurrent Axis I Disorder (including Major Depressive Disorder) must be secondary to the primary diagnosis of PTSD.
• Chronic pain levels requiring use of any opiate medications with the exception of Tramadol. Patients are allowed the use of Tramadol at 25-50 mg per day dosing.
• Any condition or disorder that may cause neuropsychiatric sequelae (e.g., Parkinson's disease, stroke, seizures, or TBI).
• Patients with a history of intolerance or hypersensitivity to minocycline or other tetracycline antibiotics, or prior tetracycline use 2 months prior to the Screening Visit.
• Concomitant treatment with penicillin or other antibiotics, or treatment with antibiotics for greater than 7 days in the past month.
• Use of aspirin, non-steroidal anti-inflammatory agents (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors for \< 6 months prior to study entry or dose changes after study entry. Limited as-needed use is permitted prior to study entry but not during the study.
• Use of statins will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines.
• Use of concomitant anti-coagulant drugs (except low-dose aspirin) as minocycline has been shown to depress plasma prothrombin activity.
• Any degree of hepatic or renal failure that in the Investigator's judgement would pose a safety risk for treatment with minocycline.
• Conditions which may be negatively affected by minocycline treatment, such as active inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease).
• A history of C. difficile colitis.
• Patients who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
• Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
• Women who are pregnant or plan to become pregnant during the study. All women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and throughout the study. Sexually active women participating in the study must use a medically acceptable form of contraception.

Sponsors & Collaborators

• Sriram Ramaswamy: lead
• Creighton University: collaborator

Study Sites (1)

VA Nebraska-Western Iowa Health Care System

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Sriram Ramaswamy, MD
• Organization: VA Nebraska-Western Iowa Health Care System

Sriram.Ramaswamy@va.gov

402-995-4712

Study Officials

• Sriram Ramaswamy, MD

  VA Nebraska Western Iowa Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Psychiatrist

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: November 13, 2017
• Study Start: May 10, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 9, 2020
• Results First Posted: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)